MiniMaster Series
DB Tube Mini Mand Right 1ST Molar 022 Cast Conv TQ=-25 R=8 3.5MM W/Hook & MR PAD
34manufacturers in China registered for this device type
77catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (20), Jiangsu (4), Guangdong (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 34. All 34 manufacturers in China registered for Tube, Orthodontic
Record
| Listed by | American Orthodontics, United States |
|---|---|
| FDA product code | DZD |
| Device type | Tube, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-12-22 |
| Record revised | 2020-05-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2020-05-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 955-405CM | Withdrawn | |
| 958-845CM | Withdrawn | |
| 958-444CM | Withdrawn | |
| 996-458CM | Withdrawn | |
| 957-321CMR | Withdrawn | |
| 957-301CMR | Withdrawn | |
| 955-458CM | Withdrawn | |
| 955-311CM | Withdrawn | |
| 956-459CM | Withdrawn | |
| 956-434CM | Withdrawn | |
| 996-301CMR | Withdrawn | |
| 955-444CM | Withdrawn | |
| 956-406CM | Withdrawn | |
| 996-434CM | Withdrawn | |
| 996-457CM | Withdrawn | |
| 955-435CM | Withdrawn | |
| 996-438CM | Withdrawn | |
| 998-444CM | Withdrawn | |
| 956-439CM | Withdrawn | |
| 955-438CM | Withdrawn | |
| 955-301CMR | Withdrawn | |
| 958-321CML | Withdrawn | |
| 956-851CM | Withdrawn | |
| 957-844CM | Withdrawn | |
| 958-301CML | Withdrawn | |
| 996-437CM | Withdrawn | |
| 955-440CM | Withdrawn | |
| 958-311CM | Withdrawn | |
| 997-435CM | Withdrawn | |
| 996-773CM | Withdrawn | |
| 996-408CM | Withdrawn | |
| 956-321CML | Withdrawn | |
| 996-440CM | Withdrawn | |
| 955-852CM | Withdrawn | |
| 996-772CM | Withdrawn | |
| 956-408CM | Withdrawn | |
| 955-850CM | Withdrawn | |
| 997-443CM | Withdrawn | |
| 956-443CM | Withdrawn | |
| 955-321CMR | Withdrawn | |
| 998-435CM | Withdrawn | |
| 956-310CM | Withdrawn | |
| 956-437CM | Withdrawn | |
| 996-435CM | Withdrawn | |
| 997-434CM | Withdrawn | |
| 996-436CM | Withdrawn | |
| 996-444CM | Withdrawn | |
| 955-436CM | Withdrawn | |
| 996-321CML | Withdrawn | |
| 996-459CM | Withdrawn | |
| 996-407CM | Withdrawn | |
| 958-435CM | Withdrawn | |
| 996-439CM | Withdrawn | |
| 996-774CM | Withdrawn | |
| 996-313CM | Withdrawn | |
| 956-457CM | Withdrawn | |
| 957-310CM | Withdrawn | |
| 996-410CM | Withdrawn | |
| 955-313CM | Withdrawn | |
| 996-443CM | Withdrawn | |
| 996-775CM | Withdrawn | |
| 955-407CM | Withdrawn | |
| 957-846CM | Withdrawn | |
| 996-301CML | Withdrawn | |
| 996-321CMR | Withdrawn | |
| 958-313CM | Withdrawn | |
| 957-443CM | Withdrawn | |
| 996-312CM | Withdrawn | |
| 957-434CM | Withdrawn | |
| 957-312CM | Withdrawn | |
| 958-847CM | Withdrawn | |
| 956-301CML | Withdrawn | |
| 996-310CM | Withdrawn | |
| 956-853CM | Withdrawn | |
| 996-409CM | Withdrawn | |
| 956-312CM | Withdrawn | |
| 996-311CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tube, Orthodontic | Forestadent Bernhard Förster GmbH | 2,336 |
| Generic Buccal Tubes | American Orthodontics | 799 |
| Tube, Orthodontic | G & H Wire Company | 758 |
| Leone SPA | Leone SPA | 722 |
| RMO | RMO | 697 |
| Tube, Orthodontic | Dentaurum GmbH & Co. KG | 602 |
| LP Low Profile | American Orthodontics | 506 |
| 3M™ Unitek™ Victory Series™ | 3M Unitek | 434 |
| Buccal Tubes | American Orthodontics | 356 |
| Peerless Buccal Tube | Ormco Corporation | 331 |
| Empower Tube | American Orthodontics | 296 |
| Mini Master Series | American Orthodontics | 289 |
Showing 12 of 333. All products under Tube, Orthodontic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.